CardiomyopathyNCT01856400
Ventricular Arrhythmias in Uremic Cardiomyopathy
An observational study of Cardiomyopathy, run by Northwell Health at 1 site in United States.
Trial summary
There is a certain gene called sarcoplasmic reticulum gene (SERCA2a), which is found in heart muscle. This gene is also found in blood vessels and skin tissue. When active this gene builds a crucial protein inside the heart muscle called SERCA2a protein. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hemodialysis Patients Uremic Patients Diastolic dysfunction
Who may be able to join
- age 18 years or older
- Patients with stage 5 CKD or ESRD and those with normal CKD will be considered as possible candidates if admitted for one of the following vascular procedures
- coronary artery bypass grafting, or vascular bypass surgery, or arteriovenous fistula creation, or arteriovenous graft surgery.
- The aforementioned patients will be included if they have LVH or diastolic dysfunction and a normal LVEF on echocardiogram within one year of their scheduled surgery.
Who cannot join
- Age less than 18 ;
- Pregnancy;
- Dilated cardiomyopathy;
- left ventricular ejection fraction (LVEF) less than or equal to 50%;
- Patients on digoxin.
- antiarrhytmic medications;
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- baseline electrolyte abnormalities;
- Atrial fibrillation;
- Bundle branch block
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: Understanding the Molecular Basis of Ventricular Arrhythmias in Uremic Cardiomyopathy
There is a certain gene called sarcoplasmic reticulum gene (SERCA2a), which is found in heart muscle. This gene is also found in blood vessels and skin tissue. When active this gene builds a crucial protein inside the heart muscle called SERCA2a protein. This is responsible for regulating calcium levels inside your heart muscle. When this gene is not activated, studies have shown that it can lead to abnormal electrical currents in the heart that can lead to death. The investigators are conducting this study to prove that SERCA2a gene is inactive in patients with kidney disease. Scientists found that patient at risk for abnormal electrical currents in the heart can be tested by what they called "microvolt Twave alternans." This is a very delicate machine much more sensitive than a regular electrocardiogram that you do at the cardiology office.
Read the detailed description
This study will test the hypothesis that patients with uremic cardiomyopathy have reduced levels of SERCA2a protein compared to those with normal kidney function. We propose that such a correlation will provide convincing evidence that these patients,have a defective redistribution in intracellular calcium handling as an explanation for their increase risk in sudden cardiac death an fatal arrhythmias. To achieve our specific aims: 1) we will screen patients with end stage renal disease (ESRD) going for certain vascular procedures. 2) obtain an echocardiogram on these patients including only those with isolated diastolic dysfunction or LVH. 3) Patients who has diastolic dysfunction or LVH will be assessed for underlying microvolt (TWA) 4) vessel and skin tissue on these patients will be collected for SERCA2a quantification.
- Conditions
- Cardiomyopathy
- Keywords
- ventricular arrythmias, SERCA2a, Chronic Kidney Disease, microvolt T wave alternans
- Medical subject headings
- Cardiomyopathies, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular basis of ventricular arrythmias in uremic cardiomyopathy
To assess the expression of SERCA2a gene expression in Uremic Cardiomyopathy patients to see if the degree of expression is implicated in ventricular arrythmias
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startJan 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Suzanne El-Sayegh, Northwell Health
- Investigators
- Suzanne El-Sayegh, MD, Principal investigator, SIUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856400
- Sponsor's protocol ID
- 09-053
- Status last verified
- Jan 2014
- First submitted
- 14 May 2013
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Molecular Basis of Ventricular Arrhythmias in Uremic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01856400
- Acronym / sponsor ID
- 09-053
- Conditions
- Cardiomyopathy
- Keywords
- ventricular arrythmias, SERCA2a, Chronic Kidney Disease, microvolt T wave alternans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Jan 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a certain gene called sarcoplasmic reticulum gene (SERCA2a), which is found in heart muscle. This gene is also found in blood vessels and skin tissue. When active this gene builds a crucial protein inside the heart muscle called SERCA2a protein. This is responsible for regulating calcium levels inside your heart muscle. When this gene is not activated, studies have shown that it can lead to abnormal electrical currents in the heart that can lead to death. The investigators are conducting this study to prove that SERCA2a gene is inactive in patients with kidney disease. Scientists found that patient at risk for abnormal electrical currents in the heart can be tested by what they called "microvolt Twave alternans." This is a very delicate machine much more sensitive than a regular electrocardiogram that you do at the cardiology office.
Detailed description
This study will test the hypothesis that patients with uremic cardiomyopathy have reduced levels of SERCA2a protein compared to those with normal kidney function. We propose that such a correlation will provide convincing evidence that these patients,have a defective redistribution in intracellular calcium handling as an explanation for their increase risk in sudden cardiac death an fatal arrhythmias. To achieve our specific aims: 1) we will screen patients with end stage renal disease (ESRD) going for certain vascular procedures. 2) obtain an echocardiogram on these patients including only those with isolated diastolic dysfunction or LVH. 3) Patients who has diastolic dysfunction or LVH will be assessed for underlying microvolt (TWA) 4) vessel and skin tissue on these patients will be collected for SERCA2a quantification.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis Patients Uremic Patients Diastolic dysfunction
Key inclusion criteria (4 listed)
- age 18 years or older
- Patients with stage 5 CKD or ESRD and those with normal CKD will be considered as possible candidates if admitted for one of the following vascular procedures
- coronary artery bypass grafting, or vascular bypass surgery, or arteriovenous fistula creation, or arteriovenous graft surgery.
- The aforementioned patients will be included if they have LVH or diastolic dysfunction and a normal LVEF on echocardiogram within one year of their scheduled surgery.
Key exclusion criteria (9 listed)
- Age less than 18 ;
- Pregnancy;
- Dilated cardiomyopathy;
- left ventricular ejection fraction (LVEF) less than or equal to 50%;
- Patients on digoxin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Molecular basis of ventricular arrythmias in uremic cardiomyopathy
Time frame: At time of surgery
To assess the expression of SERCA2a gene expression in Uremic Cardiomyopathy patients to see if the degree of expression is implicated in ventricular arrythmias
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne El-Sayegh, MD principal investigator
SIUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular basis of ventricular arrythmias in uremic cardiomyopathy (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.